|Publication number||US7582063 B2|
|Application number||US 10/432,061|
|Publication date||Sep 1, 2009|
|Filing date||Nov 21, 2001|
|Priority date||Nov 21, 2000|
|Also published as||DE10057832C1, DE50113793D1, EP1337182A1, EP1337182B1, US20040039303, US20090247906, WO2002041779A1|
|Publication number||10432061, 432061, PCT/2001/13514, PCT/EP/1/013514, PCT/EP/1/13514, PCT/EP/2001/013514, PCT/EP/2001/13514, PCT/EP1/013514, PCT/EP1/13514, PCT/EP1013514, PCT/EP113514, PCT/EP2001/013514, PCT/EP2001/13514, PCT/EP2001013514, PCT/EP200113514, US 7582063 B2, US 7582063B2, US-B2-7582063, US7582063 B2, US7582063B2|
|Inventors||Thomas Wurster, Krzysztof D. Malowaniec, Christoph Diekmann|
|Original Assignee||Pelikan Technologies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (109), Referenced by (18), Classifications (25), Legal Events (4) |
|External Links: USPTO, USPTO Assignment, Espacenet|
Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US 7582063 B2
A blood testing apparatus includes a device for withdrawing blood, a membrane-type testing element, an evaluating device, and a display device forming a complete system which can be manipulated as a single piece of apparatus. Multiple testing elements can be inserted into the apparatus and brought successively to a work position for carrying out several measurements. The blood withdrawing device includes multiple pricking elements. One pricking element is pushed through one testing element and pricks the surface of the skin of a user. The pricking position is disposed so that blood withdrawn from the surface of the skin can impinge upon the testing element.
1. A blood testing apparatus with a blood extraction device, comprising: a lancing element drive mechanism, a plurality of test means, positioned on a rotatable, disposable device that can be inserted into the apparatus; a plurality of lancing elements being disposed on the dispoable device such that each of a lancing element perforates through a test means when the drive mechanism acts against a lancing element, each of a lancing element being associated with a test means and prior to actuation each of a lancing element is gripped to the lancing element drive mechanism, electronics for analysis, and a display which form a complete system to be manipulated as a single apparatus, the display configured to display additional evaluation and display functions and comparisons with previously stored measurement or evaluation data, saved if desired and their results displayed if desired, wherein launch of a lancing element is initiated with a contact sensor or with a pressure point mechanism, the plurality of test means being arranged radially around an axis of rotation of the rotatable, disposable device having a circumferential wall section that runs cylindrically on an outer periphery, the test means being positioned in appropriate recesses in a circumferential wall section of the disposable device in a concentric arrangement around the axis of rotation, each of the test means and at least one lancing element having a longitudinal axis that is substantially perpendicular relative to the axis of rotation; the test means being disposed with surfaces normal in a radial direction with respect to a center of the rotatable, disposable device.
2. The blood testing apparatus from claim 1, wherein the lancing element remains in the test means following the lancing procedure and can be removed with the test means from an operating position in order to position a new test means there.
3. The blood testing apparatus from claim 1 wherein the lancing element is manageably conjoined to the test means and can be inserted together with the test means into the apparatus and can be deployed to an operating position.
4. The blood testing apparatus from claim 1, wherein spent lancing elements and test means can be ejected or brought to a storage and disposal position.
5. The blood testing apparatus claim 1, wherein the apparatus has an essentially circular disc-shaped outer contour.
6. The blood testing apparatus from claim 1, characterized by a safety mechanism which permits initiation of the lancing procedure only when the apparatus is manipulated correctly.
7. The blood testing apparatus from claim 1, wherein the number of test means to be manipulated as a unit is 5 to 75.
8. The blood testing apparatus from claim 1, wherein the number of test means to be manipulated as a unit is 14-28.
9. The blood testing apparatus from claim 1, wherein the at least one lancing element is disposed on the rotatable, disposable device.
10. The blood testing apparatus from claim 9, wherein the rotatable, disposable device comprises a first housing section for the test means and a second housing section for the at least one lancing elements.
11. The blood testing apparatus from claim 9, wherein the rotatable, disposable device has a central recess which has a drive mechanism and an electric-motor propulsion means for one of a carrier and the drive mechanism.
12. The blood testing apparatus from claim 9, wherein the rotatable, disposable device has a spring means to retract the at least one lancing element from the skin surface of the user.
13. The blood testing apparatus from claim 1, wherein the apparatus has oppositely located a lancing position against which to place the skin surface to be lanced and a release position to initiate the lancing procedure by manual actuation of a release button.
14. The blood testing apparatus from claim 13, wherein the apparatus is adapted to be held by a user holding the apparatus at the lancing position and the release button with two fingers.
15. The blood testing apparatus from claim 13, wherein the release button is ergonomically shaped to be grasped by the thumb of a user.
16. The blood testing apparatus from claim 13, wherein the release button has a pressure point which must be overcome in order to release the lancing element.
The invention relates to a blood testing apparatus for determining an analyte, such as fructosamine, lactate, cholesterol, specifically glucose, from minimal quantities amounts of blood extracted immediately prior from a user.
The invention deals with blood testing apparatus of the kind that are configured with a membrane-like test means defining a field of measurement, said test means being wetted with the minimal amount of blood extracted and including test reagents, having an evaluation device comprising electronics working optically, preferably using reflectance analysis, or electronically and having a display device, where the aforementioned components form a complete system which can be manipulated as a single apparatus.
A diagnostic apparatus of this type is known from U.S. Pat. No. 4,787,398. This blood glucose monitoring apparatus comprises a housing structure with a push-rod arrangement to actuate a lancing element and having an evaluation device and a display device. For each measurement, a replaceable unit must be positioned in the housing structure, comprising the lancet and a test means to be wetted with blood in the form of a test strip. This replaceable unit is discarded after each use.
Using this as the point of departure, the object of the present invention is to further develop a blood testing apparatus which has fewer components to be manipulated individually and is thus easier to operate and more user friendly.
A blood testing apparatus known from EP 0 449 525 A1 similarly comprises an integral release device for a lancing element. Before each use, a new lancing element has to be manually inserted into the release device as part of the blood extraction device and then a test strip has to be inserted into the apparatus.
U.S. Pat. No. 4,627,445 shows a complete system for a glucose measuring apparatus in the aforesaid sense. But before each measurement a new replaceable unit of lancing element and test means has to be assembled to a body and removed afterwards.
U.S. Pat. No. 5,951,492 shows a similar device. According to this publication, a disposable unit comprises a capillary tube on the upper end of which a test strip is provided which is exposed to the minimal quantity of blood extracted. The capillary tube is configured at its lower end with a lancing element. Again, before and after each measurement a new disposable unit of the type just described must be installed or removed. According to a further embodiment, a transverse slot is provided in the area of the face of the apparatus facing the user, through which a porous test membrane with a carrier can be inserted, which is then penetrated by the lancing element in the lancing procedure.
According to one embodiment, U.S. Pat. No. 5,971,941 shows a complete system in the aforesaid sense, where a cartridge with unused srip-like test means is inserted into a housing and a suitable test means can then be brought into a suitable operating position by means of a driver. Through a triggering device, which forms part of the blood extraction device, a lance contained in a suitable test strip is urged outward by mean of a pushrod to pierce the surface of the user's skin so that capiliary blood can be obtained for analysis. More detailed information on how the analysis is performed cannot be obtained from this publication. According to a further embodiment described in this publication, a cylindrical disposable attachment or insert is descried which has a lancet and a tablet-shaped test membrane with an opening for the lancing device. This attachment or insert is then inserted into a recess of a pushrod arrangement which forces the lancing element outward to extract blood. Once again, before and after each test procedure the disposable unit must be installed or removed.
The object, explained at the beginning, to create a user-friendly improvement of a blood testing apparatus of this type which ensures a safe supply of blood for the test means with the smallest possible quantity of blood, is achieved under the invention through a plurality of test means which can be inserted into the apparatus and brought into an operating position to perform several measurements in succession where they can interact with the evaluation device, through the blood extraction device similarly having a plurality of lancets, and when a suitable test means is positioned in the operating position, a lancet can be thrust through the test means and can pierce the surface of the user's skin which is positioned in a lancing position aligned with the operating position so that blood emanating from the skin can impinge directly on the test means.
Under the invention, installation or removal before and after each test, measurement or analysis procedure is to be avoided. For this reason, a plurality of test means and preferably a number of lancing elements corresponding exactly to number of test means is furnished in the blood testing apparatus, which can be brought into the operating position in succession and then interact with the blood extraction device when it is actuated or released. A lancing element located in the operating position is driven through the membrane-like test means and pierces the surface of a user's skin, so that the minimal quantity of blood obtained directly wets the membrane-like test means without having to penetrate capillary tubes or slots, which in turn require quantities of blood. Any number of switching and driving means powered mechanically or by an electric motor are conceivable to move the test or lancing means to the operating position and to actuate the lancing means. The number of test means, which are preferably handled as a unit, and advantageously of the lancing means as well, is preferably 5 to 75, and specifically 14–28. The numbers 14 and 28 correspond to a 2 or 4-week rhythm if one analysis is made per day.
After the evaluation and display of the result of the analysis, or of the blood glucose level, the specific test means is moved from its operating position and the next succeeding test means is brought into the operation position preferably immediately.
The lancing element could be withdrawn from the test means again before this process. It proves to be advantageous if the lancing element remains in the test means following the lancing procedure and can be removed with it from the operating position to position a new test means. The lancing element can also be retracted far enough so that it does not project beyond a finger rest area in the apparatus. However, this is not absolutely necessary.
In accordance with a further aspect of the invention, it is conceivable that the lancing element is connected to the membrane-like test means before the lancing procedure and can be inserted with it into the apparatus and moved to the operating position. The lancing element can already be inserted into the test means or be stuck through it.
Following a lancing and measurement procedure, spent lancing elements and test means can be ejected individually or together, or they can be taken to a storage and disposal position.
In a further aspect of the invention, the test means are disposed on a carrier which is movable, preferably rotatable, with respect to a housing base and inserted with the carrier into the housing base of the apparatus. The test means can then be brought in succession to the operating position by rotating the carrier or moved from the operating position to a storage and disposal position.
The test means are advantageously so disposed on the carrier that they can be positioned in a radial direction with respect to the rotatable carrier. Furthermore, the carrier preferably has an annular configuration and is carried rotatably about the center of the ring.
Protection against dirt, contamination and the effects of humidity is preferably provided. The carrier can be configured advantageously as a closed cartridge. The carrier can then have apertures which can be closed or withdrawn in the manner of a window or diaphragm to interact with the drive mechanism and allow the lancing element to extend to perform the lancing procedure or allow blood to reach the test means. As further protection, particularly against humidity, the test means can alternatively or additionally be encased in foil covers which can be removed in the operating position.
The blood extraction device is advantageously housed inside the annulus with the several lancing elements. It is conceivable that a release device, which is known in the art and described in the aforementioned publications, is housed within the annulus. For example, a pushrod-like driver arrangement is implemented, which operates on the side of a lancing element away from the body when located in the operating position such that the lancing element pierces the skin surface of a user. It would also be conceivable that a specific lancing element in the operating position is held in a wedging arrangement between the opposably movable jaws of the driving organ, so that by moving the driving organ forward and back the lancing element can be extended to the outside of the apparatus and retracted again. In any case, the drive unit of the blood extraction device, which thrusts a specific lancing element through the membrane-like test means into the skin surface of a user, forms a part of the housing or base apparatus as does the evaluation and display device. The membrane-like test means and the lancing elements, on the other hand, represent disposable elements which are inserted in a predetermined configuration, such as being located on a carrier, into the housing base.
It proves furthermore to be advantageous if, as already mentioned, the lancing elements, on a rotatable carrier, preferably on the same carrier as the test means, are inserted into the blood testing apparatus. By rotating the carrier or carriers, a specific lancing element is similarly brought into the operating position, namely into a position where it is struck by the driving organ of the blood extraction device or is gripped in a wedging arrangement and can be moved suddenly to perform the lancing procedure.
It proves to be of overall advantage if the blood testing apparatus has a basically circular disc-shaped outer contour, as it can thus be gripped and held comfortably in the user's hands.
In a further aspect of this inventive idea, the apparatus has oppositely located a lancing position for positioning the skin surface to be pierced and a release position to trigger the lancing procedure by manually actuating a release button.
The apparatus is advantageously held by a user holding the apparatus with two fingers at the lancing position and the release button. The release button has an advantegeous ergonomic shape for grasping by the thumb of a user. If preferably has a pressure point which must be overcome in order to initiate the lancing operation. For safety reasons, it proves to be advantegeous if the lancing operation can only be initiated when both fingers have taken up their correct position. This could be implemented through contact sensors or through a pressure point mechanism.
It must be pointed out that instead of a needle or lancet-shaped lancing element, which is moved preferably suddenly in the direction of the skin surface of a user to perform the lancing procedure in a manner known in the art, for example, by releasing a spring-tensioned driving device, a laser beam can also be used. The required source of laser light is among the non-disposable system components of the blood testing apparatus. With this solution as well, a specific test means can be furnished with an opening through the laser beam can pass.
In accordance with a further inventive aspect, the blood testing apparatus can be configured in the style of a wrist watch, that is to say it can have a housing base modeled after a wrist watch casing. A viewing side of the blood testing apparatus can then have a face as with a familiar watch, or a digital display. The digital display can be configured to display time and/or additional functions and to display data or information gathered by the blood testing apparatus as needed.
It can prove further advantageous if the blood testing apparatus has a removable, preferably upwardly pivotable, cover which has access to the interior of the blood testing apparatus, specifically to insert or replace the carrier for the test means and/or lancing elements. In the design of the external appearance of the blood testing apparatus in the style of a wrist watch, or even in the style of a pocket watch, it can prove advantageous if the removable or upwardly pivotable cover simultaneously comprises the face or some other time display device which is raised or pivoted upward with the cover.
In accordance with another inventive aspect, the cover when opened can reveal a view of a display device in the blood testing apparatus, which can be located either on the inward facing side of the raised cover or is revealed by the removal or upward pivoting of the cover. It can further prove to advantageous if a second removable or upwardly pivotable cover is furnished under the first removable or upwardly pivotable cover, which second cover permits or closes off access to the interior of the blood testing apparatus. This second cover could then contain the display device for the blood testing apparatus on its outer side, which can serve simultaneously as a time display. To read the data and information gathered by the blood testing apparatus, the first cover is opened so that a user can view the display device on the exposed viewing side of the second cover, or on the inner side of the first cover. The second cover is opened only to replace the test means or lancing elements.
In an aspect of the blood testing apparatus in the style of a wrist watch casing, it proves advantageous if a finger rest is furnished at the “6 o'clock” or “12 o'clock” position to perform the lancing process to draw a minimal amount of blood, or in the respective areas where the watch strap attaches. This permits convenient operability, which also has a positive effect on good wetting function, since the particular test means (when the test means are arranged essentially perpendicular to the radial direction) is aligned horizontally when the blood is extracted, which promotes even wetting.
BRIEF DESCRIPTION OF THE DRAWING
Additional features, details and advantages of the invention can be found in the appended claims and the drawing and the description to follow of a preferred embodiment of the invention.
In the drawing:
FIG. 1 shows a schematic arrangement of a first aspect of a blood testing apparatus in accordance with the invention;
FIG. 2 shows a sectional view of the blood testing apparatus from FIG. 1;
FIG. 3 shows an exploded view of a second aspect of a blood testing apparatus in accordance with the invention;
FIG. 4 shows an exploded view of the carrier for test means and lancing elements of the apparatus from FIG. 3;
FIG. 5 shows an isometric view of the assembled blood testing apparatus from FIG. 3;
FIG. 6 shows an isometric view of a third aspect of a blood testing apparatus in accordance with the invention;
FIG. 7 shows an isometric view of the blood testing apparatus from FIG. 6 with the first cover raised;
FIG. 8 shows an isometric view of the blood testing apparatus from FIG. 7 with the first and second covers raised and
FIG. 9 shows an isometric view corresponding to FIG. 8 of a fourth aspect of the blood testing apparatus in accordance with the invention.
FIGS. 1 and 2 show a schematic view of a blood testing system in accordance with the invention, where FIG. 1 represents a view into the interior with the cover removed and FIG. 2 represents a schematic sectional view. The blood testing apparatus in the form of a blood glucose measuring apparatus, identified as a whole with the reference numeral 2, comprises a housing base 4 and a removable cover 6. A blood extraction device 8 with a drive mechanism 10 and a lancing element in the form of a needle is accommodated in the interior of the housing base 4. The blood extraction device 8 interacts with a release button 14 on the narrow outer side of the disc-shaped housing base 4. The drive mechanism comprises a driving spring and a return spring 16, 18, both of which are indicated only schematically. Through mechanical coupling and control means 20, pressing the release button 14 and overcoming a pressure point mechanism 22 releases the drive mechanism 10, so that under the pre-load of the driving spring 16 a plunger 24 moves radially outward at speed, wedging the lancing element 12 between jaws 26 and driving it radially outward and immediately afterward retracting it again slightly under the effect of the return spring 18. The lancing element 12 penetrates forward briefly across the finger rest 28 lying radially opposite the release button on the outside of the housing base 4, which defines a lancing position, and briefly pierces the skin surface of a user with predetermined speed and depth of penetration to allow a minimal quantity of blood to escape.
As the lancing element 12 moves outward at speed, a membrane-like test means 30, which is located in a manner to be described in greater detail in the immediate vicinity behind the finger rest 28, is penetrated by the lancing element 12. The blood emanating from the skin surface then directly wets the outwardly facing surface of the membrane-like test means 30, which is furnished with reagents.
As can be seen from the Figures, a plurality of test means 30 is furnished with the lancing elements allocated to each of the test means 30. The test means 30 and the lancing elements 12 are located on an annular carrier 32, for example, eight or ten pairs of test means 30 and lancing elements 12 are located around the circumference or partial circumference of the annular carrier 32. With the cover 6 removed, the carrier 32 can be inserted into a locating device 34 of complementary shape which can be rotated around the center of the ring. Embodiments would also be conceivable in which the cover 6 does not need to be removed in order to insert the carrier 32, but which have a recess open to the top to insert a cassette-type closed carrier 32. This provides protection against dirt, contamination and the effects of humidity. The carrier 32 can have available apertures which can be closed and withdrawn like a window or diaphragm in order to interact with the drive mechanism and allow the lancing means to extend to the outside to perform the lancing procedure or to allow blood to reach the test means. As further protection, specifically against humidity, the test means could alternatively or additionally be covered with foil wrappers which can be removed in the operating position.
As can be seen from the Figures, the membrane-like test means 30 are disposed such that they are disposed with their surface normal in the radial direction with respect to the center of the ring. By actuating a sliding button 36 on the outside of the housing base 4, the locating device 34, and with it the carrier 32 positioned in it and held frictionally in place, are rotated into a discrete further angular position, so that the pairs of test means 30 and lancing elements 12 are brought in succession into an operating position in which the lancing element 12 can interact with the drive mechanism 10. In this way the blood glucose measuring apparatus is prepared by insertion of the preferably cassette-type carrier 32 with a number, for example, of ten test means 30 and lancing elements 12 for ten measurements. Following a measurement, the button 36 only has to be actuated to bring the next pair of test means 30 and lancing element 12 into the operating position. Additional installation and removal steps before and after a particular measuring procedure are not required. Spent test means 30 and test elements are brought in a clockwise direction with the carrier 32 to a storage or disposal position, which follows the operating position. It would also be conceivable to furnish an ejection mechanism which ejects a particular spent pair for disposal, which is regarded as less preferred since proper disposal must take place immediately. The protected arrangement of the spent pairs inside the cassette-type carrier 32 is preferred instead. After the predetermined number of tests are performed, the cassette-type-like carrier 32 is removed and disposed of and replaced with a new one.
Because the lancing element 12 penetrates the membrane-like test means 30 in the lancing process, preferably in its center, the test means 30 is ensured of being positioned in immediate proximity to the point of penetration on the skin surface of the user. The blood emanating there is immediately and, most importantly, evenly deposited on the test area of the test means 30, even when only small quantities of blood are available.
In the aspect shown, the lancing elements 12 are disposed on the carrier 32 such that they perforate the center of the test means 30 when the drive mechanism 10 acts against them. To achieve this, it can prove to be advantageous if the lancing elements 12 are disposed in such a way on the carrier 32 that the point has penetrated into the accompanying test means 30, at least partially in the direction of their thickness. This acts as an aid to positioning. A continuous guide opening can also be furnished in the test means 30. The diameter of the guide opening should preferably be smaller than the outside diameter of the lancing element 12 to prevent blood from penetrating through a gap between the outer surface of the lancing element 12 and the guide opening toward the back side of the test means 30.
An evaluation device 38 known in the art is also furnished in the interior of the glucose measuring apparatus. An optical, preferably reflectance analysis unit, is indicated schematically in FIG. 2. The evaluation device 38 can comprise a light source 40 and a sensor 42 for the reflectance measurement of the change of color of the back side of the membrane-like test means 30, where the analysis reaction of the glucose contained in the blood sample with the test or proof reagents takes place (enzymatic redox reaction). The principles of an optical analysis device are described, for example, in EP-A-0 654 659 and EP-A-0 475 692.
In the case where the electrochemical measurement principle is applied, the optical evaluation device is dispensed with. The enzymatic redox reaction is quantified instead through the detection of electrical current or voltage at an electrode (described, for example, in EP-A-0 552 223).
The evaluation device 38 comprises in a known way electronics for analysis which interact with a display device 44 which indicates, for example, in the form of an LCD display the test result, perhaps the blood glucose content. By means of the evaluation device, additional evaluation and display functions and comparisons with previously stored measurement or evaluation data could be performed, saved if necessary and their result displayed.
The blood testing apparatus under the invention thus represents a complete system which does not require the separate manipulation of test strips or lancets during the blood glucose measurement. By inserting the cassette-type carrier 32 with test means 30 and lancing elements 12, the apparatus is prepared for a specific number of measurements, for which no additional installation or removal steps or the separate manipulation of additional aids is required.
FIGS. 3 to 5 show a second aspect of the blood testing apparatus under the invention, where components identical to the first aspect are identified with the same reference numeral. In accordance with this aspect, the blood testing apparatus has a housing base 4 modeled after or approximating the basic shape of a wrist watch casing, where the dimensions, specifically the depth of the housing base 4, can be enlarged compared with traditional wrist watch casings. Further indicated are installation areas 45 for a specifically flexible pin of a normal watch strap. A dome-shaped centering means 46 is depicted in the interior of the housing base 4, which appears cuboid in plan view but which has two segmental side sections 48 which are configured concentric to an axis of rotation 50 and provide a positioning aid when inserting a carrier 32 for test means 30 and lancing elements 12. Further, a servo motor 52 (not shown in detail) is housed in the centering means 46.
The servo motor 52 can serve to move the carrier 32 to move a spent test means 30 from an operating position to a disposal position and simultaneously to position a still unused test means 30 in the operating position. It is not entirely excluded that the servo motor 52 can also serve to power the only schematically represented drive mechanism 10. The drive coupling of the servo motor 52 with the carrier 32 could, for example, be formed through a pinion gear, crown wheel, bevel gear or miter gear connection between a rotatingly driven wheel of the servo motor 52 and correspondingly configured, specifically sprocket-shaped matching gear means on the carrier 32.
As shown in FIGS. 3 and 4, the carrier 32 is configured in the shape of an annular disc-shaped cassette 54. The cassette comprises a lower housing section 56 with an annular disc-shaped floor section 58 with a circular access opening 60 and with circumferential wall section 62 running cylindrically on the outer periphery. The test means 30 are furnished in appropriate recesses 64 in the circumferential wall section 62 in a concentric arrangement around the axis of rotation 50. A similarly shaped upper housing section 68, which comprises a number of radially aligned lancing elements 12 corresponding to the number of test means 30, can be inserted into the lower housing section 56. Spring means 69 can also be seen, specifically in the form of closed loops, which hold the lancing elements 12. When the skin surface of a user is pierced, these spring elements 69 are tensioned and are able to retract the particular lancing element 12 again following the penetration through the drive mechanism 10. This arrangement of lancing elements 12 is located radially outside the aforementioned opening 60 and thus radially outside the dome-shaped centering means 46, which simultaneously comprises the drive mechanism 10 which is disposed radially inside the arrangement of lancing elements 12. The lower housing section 56 and the upper housing section 68 inserted into it are joined together so that they cannot turn and can be rotated in common as a carrier 32 around the axis 50 to bring test means 30 and lancing elements 12 into the operating position, or shift them from the operating position to a disposal position.
The button 36 schematically represented in FIG. 3 is linked to the drive mechanism 10 to actuate it. The control rod 66 suggested there running radially runs either above or below the carrier 32. As mentioned, the actuation of the drive mechanism 10 could also be achieved with a motor, preferably electrically controlled.
Finally the blood testing apparatus comprises a cover 6 which can be modeled after the face of an electronic watch and can have a display device 44, for example, in the form of an LCD display. This cover then forms the viewing side of the blood testing apparatus, as can be seen from FIG. 5.
FIG. 6 shows an isometric view corresponding to FIG. 5 of a blood testing apparatus with a watch face 68 on the viewing side of a pivotally articulated cover 6. It should also be mentioned that a finger rest 28 is furnished at the “6 o'clock” position with reference to the face 68, which forms the operating position in which the skin surface is briefly penetrated by the lancing element 12 when the drive mechanism 10 is released. This arrangement proves to be advantageous insofar as the user (standing) can place the hand on the stomach when performing the lancing procedure and then position the thumb of the other hand on the finger rest 28. When the lancing process is triggered in this position, the membrane-like test means 30 is disposed essentially horizontally and the minimal amount of blood can wet the test means following gravity.
FIG. 7 shows the blood testing apparatus from FIG. 6 with the first cover 6 pivoted up so that the view of the upper side of a second cover 70 is uncovered where, in accordance with this embodiment, the display device 44 for the blood testing apparatus is located. The display device 44 for the blood testing apparatus is thus separated spatially from the face 68 or the display unit for time. Naturally, the display device 44 could also serve to display time.
FIG. 8 shows the blood testing apparatus from FIG. 7 with the second cover 70 likewise raised so that access to the housing base 4 for inserting and removing a carrier cartridge is possible.
Finally, FIG. 9 shows an isometric view corresponding to FIG. 8 of a further embodiment, according to which the display device 44 for blood analysis is furnished on the inner side of the first cover 6.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2801633||Feb 17, 1954||Aug 6, 1957||Ehrlich Joseph C||Lancets|
|US4338174||Jan 8, 1979||Jul 6, 1982||Mcneilab, Inc.||Electrochemical sensor with temperature compensation means|
|US4420564||Nov 4, 1981||Dec 13, 1983||Fuji Electric Company, Ltd.||Blood sugar analyzer having fixed enzyme membrane sensor|
|US4590411||Sep 7, 1982||May 20, 1986||Kelly H P G||Linear motors and control circuitry therefor|
|US4627445||Apr 8, 1985||Dec 9, 1986||Garid, Inc.||Glucose medical monitoring system|
|US4637393||Jun 21, 1984||Jan 20, 1987||Microsurgical Equipment Limited||Surgical instrument|
|US4758323||May 7, 1984||Jul 19, 1988||Genetics International, Inc.||Assay systems using more than one enzyme|
|US4787398||Jul 25, 1986||Nov 29, 1988||Garid, Inc.||Glucose medical monitoring system|
|US4794926 *||Nov 24, 1986||Jan 3, 1989||Invictus, Inc.||Lancet cartridge|
|US4886499||Dec 4, 1987||Dec 12, 1989||Hoffmann-La Roche Inc.||Portable injection appliance|
|US4924879||Oct 7, 1988||May 15, 1990||Brien Walter J O||Blood lancet device|
|US4999582||Dec 15, 1989||Mar 12, 1991||Boehringer Mannheim Corp.||Biosensor electrode excitation circuit|
|US5019974||Feb 22, 1990||May 28, 1991||Diva Medical Systems Bv||Diabetes management system and apparatus|
|US5029583||Nov 6, 1989||Jul 9, 1991||Personal Diagnostics, Inc.||Optical analyzer|
|US5035704||Mar 7, 1989||Jul 30, 1991||Lambert Robert D||Blood sampling mechanism|
|US5047044||Feb 23, 1990||Sep 10, 1991||Thorne, Smith, Astill Technologies, Inc.||Medical droplet whole blood and like monitoring|
|US5108889||Oct 12, 1988||Apr 28, 1992||Thorne, Smith, Astill Technologies, Inc.||Assay for determining analyte using mercury release followed by detection via interaction with aluminum|
|US5178142||Jul 3, 1991||Jan 12, 1993||Vivascan Corporation||Electromagnetic method and apparatus to measure constituents of human or animal tissue|
|US5181910||Feb 28, 1991||Jan 26, 1993||Pharmacia Deltec, Inc.||Method and apparatus for a fluid infusion system with linearized flow rate change|
|US5181914||May 6, 1992||Jan 26, 1993||Zook Gerald P||Medicating device for nails and adjacent tissue|
|US5183042||Jul 3, 1991||Feb 2, 1993||Vivascan Corporation||Electromagnetic method and apparatus to measure constituents of human or animal tissue|
|US5216597||May 28, 1991||Jun 1, 1993||Diva Medical Systems Bv||Diabetes therapy management system, apparatus and method|
|US5228972||May 30, 1989||Jul 20, 1993||Daikin Industries, Ltd.||Apparatus for measuring concentration of test substance in liquid|
|US5251126||Oct 29, 1990||Oct 5, 1993||Miles Inc.||Diabetes data analysis and interpretation method|
|US5277181||Dec 12, 1991||Jan 11, 1994||Vivascan Corporation||Noninvasive measurement of hematocrit and hemoglobin content by differential optical analysis|
|US5312590||Apr 24, 1989||May 17, 1994||National University Of Singapore||Amperometric sensor for single and multicomponent analysis|
|US5352351||Jun 8, 1993||Oct 4, 1994||Boehringer Mannheim Corporation||Biosensing meter with fail/safe procedures to prevent erroneous indications|
|US5371687||Nov 20, 1992||Dec 6, 1994||Boehringer Mannheim Corporation||Glucose test data acquisition and management system|
|US5405511||Jun 8, 1993||Apr 11, 1995||Boehringer Mannheim Corporation||Biosensing meter with ambient temperature estimation method and system|
|US5409664||Sep 28, 1993||Apr 25, 1995||Chemtrak, Inc.||Laminated assay device|
|US5438271||Nov 22, 1994||Aug 1, 1995||Boehringer Mannheim Corporation||Biosensing meter which detects proper electrode engagement and distinguishes sample and check strips|
|US5507288||May 3, 1995||Apr 16, 1996||Boehringer Mannheim Gmbh||Analytical system for monitoring a substance to be analyzed in patient-blood|
|US5508171||Feb 21, 1994||Apr 16, 1996||Boehringer Mannheim Corporation||Assay method with enzyme electrode system|
|US5510266 *||May 5, 1995||Apr 23, 1996||Bayer Corporation||Method and apparatus of handling multiple sensors in a glucose monitoring instrument system|
|US5514152||Aug 16, 1994||May 7, 1996||Specialized Health Products, Inc.||Multiple segment encapsulated medical lancing device|
|US5640954||May 5, 1995||Jun 24, 1997||Pfeiffer; Ernst||Method and apparatus for continuously monitoring the concentration of a metabolyte|
|US5643306 *||Mar 22, 1996||Jul 1, 1997||Stat Medical Devices Inc.||Disposable lancet|
|US5676143||Jul 10, 1996||Oct 14, 1997||Boehringer Mannheim Gmbh||Apparatus for analytical determination of glucose in a biological matrix|
|US5680858||Dec 10, 1993||Oct 28, 1997||Novo Nordisk A/S||Method and apparatus for in vivo determination of the concentration in a body fluid of metabolically significant substances|
|US5709699||Sep 1, 1995||Jan 20, 1998||Biosafe Diagnostics Corporation||Blood collection and testing device|
|US5738244||Jun 10, 1996||Apr 14, 1998||Bayer Corporation||Dispensing instrument for fluid monitoring sensors|
|US5741228||Feb 17, 1995||Apr 21, 1998||Strato/Infusaid||Implantable access device|
|US5746898||Nov 12, 1992||May 5, 1998||Siemens Aktiengesellschaft||Electrochemical-enzymatic sensor|
|US5770086||Jan 25, 1996||Jun 23, 1998||Eureka| Science Corp.||Methods and apparatus using hydrogels|
|US5794219||Feb 20, 1996||Aug 11, 1998||Health Hero Network, Inc.||Method of conducting an on-line auction with bid pooling|
|US5807375||Nov 2, 1995||Sep 15, 1998||Elan Medical Technologies Limited||Analyte-controlled liquid delivery device and analyte monitor|
|US5822715||Apr 18, 1997||Oct 13, 1998||Health Hero Network||Diabetes management system and method for controlling blood glucose|
|US5828943||Apr 16, 1997||Oct 27, 1998||Health Hero Network, Inc.||Modular microprocessor-based diagnostic measurement apparatus and method for psychological conditions|
|US5830219||Feb 24, 1997||Nov 3, 1998||Trex Medical Corporation||Apparatus for holding and driving a surgical cutting device using stereotactic mammography guidance|
|US5832448||Oct 16, 1996||Nov 3, 1998||Health Hero Network||Multiple patient monitoring system for proactive health management|
|US5853373||Aug 5, 1996||Dec 29, 1998||Becton, Dickinson And Company||Bi-level charge pulse apparatus to facilitate nerve location during peripheral nerve block procedures|
|US5868135||Aug 5, 1996||Feb 9, 1999||Healthtech Service Corporation||Interactive patient assistance device for storing and dispensing a testing device|
|US5871494 *||Dec 4, 1997||Feb 16, 1999||Hewlett-Packard Company||Reproducible lancing for sampling blood|
|US5879163||Jun 24, 1996||Mar 9, 1999||Health Hero Network, Inc.||On-line health education and feedback system using motivational driver profile coding and automated content fulfillment|
|US5879310||Sep 6, 1996||Mar 9, 1999||Integ, Inc.||Body fluid sampler|
|US5885211||Aug 29, 1996||Mar 23, 1999||Spectrix, Inc.||Microporation of human skin for monitoring the concentration of an analyte|
|US5887133||Jan 15, 1997||Mar 23, 1999||Health Hero Network||System and method for modifying documents sent over a communications network|
|US5893870||Jul 21, 1997||Apr 13, 1999||Actilife L.L.C.||Device and method for restricting venous flow for improved blood sampling|
|US5897493||Apr 30, 1997||Apr 27, 1999||Health Hero Network, Inc.||Monitoring system for remotely querying individuals|
|US5899855||Jun 7, 1995||May 4, 1999||Health Hero Network, Inc.||Modular microprocessor-based health monitoring system|
|US5899915||Oct 17, 1997||May 4, 1999||Angiotrax, Inc.||Apparatus and method for intraoperatively performing surgery|
|US5913310||Oct 29, 1997||Jun 22, 1999||Health Hero Network, Inc.||Method for diagnosis and treatment of psychological and emotional disorders using a microprocessor-based video game|
|US5918603||May 15, 1997||Jul 6, 1999||Health Hero Network, Inc.||Method for treating medical conditions using a microprocessor-based video game|
|US5933136||Dec 23, 1996||Aug 3, 1999||Health Hero Network, Inc.||Network media access control system for encouraging patient compliance with a treatment plan|
|US5942102||May 7, 1997||Aug 24, 1999||Usf Filtration And Separations Group Inc.||Electrochemical method|
|US5951300||Mar 10, 1997||Sep 14, 1999||Health Hero Network||Online system and method for providing composite entertainment and health information|
|US5951492||May 16, 1997||Sep 14, 1999||Mercury Diagnostics, Inc.||Methods and apparatus for sampling and analyzing body fluid|
|US5951493||May 16, 1997||Sep 14, 1999||Mercury Diagnostics, Inc.||Methods and apparatus for expressing body fluid from an incision|
|US5956501||Jan 10, 1997||Sep 21, 1999||Health Hero Network, Inc.||Disease simulation system and method|
|US5960403||Aug 19, 1998||Sep 28, 1999||Health Hero Network||Health management process control system|
|US5964718||Nov 21, 1997||Oct 12, 1999||Mercury Diagnostics, Inc.||Body fluid sampling device|
|US5971941||Dec 4, 1997||Oct 26, 1999||Hewlett-Packard Company||Integrated system and method for sampling blood and analysis|
|US5972715||Dec 23, 1996||Oct 26, 1999||Bayer Corporation||Use of thermochromic liquid crystals in reflectometry based diagnostic methods|
|US5974124||Jan 21, 1997||Oct 26, 1999||Med Graph||Method and system aiding medical diagnosis and treatment|
|US5985559||May 3, 1997||Nov 16, 1999||Health Hero Network||System and method for preventing, diagnosing, and treating genetic and pathogen-caused disease|
|US5997476||Oct 7, 1997||Dec 7, 1999||Health Hero Network, Inc.||Networked system for interactive communication and remote monitoring of individuals|
|US6015392||Sep 24, 1998||Jan 18, 2000||Mercury Diagnostics, Inc.||Apparatus for sampling body fluid|
|US6023686||Jun 5, 1998||Feb 8, 2000||Health Hero Network||Method for conducting an on-line bidding session with bid pooling|
|US6032119||Jan 16, 1997||Feb 29, 2000||Health Hero Network, Inc.||Personalized display of health information|
|US6036924||Dec 4, 1997||Mar 14, 2000||Hewlett-Packard Company||Cassette of lancet cartridges for sampling blood|
|US6041253||Apr 1, 1996||Mar 21, 2000||Massachusetts Institute Of Technology||Effect of electric field and ultrasound for transdermal drug delivery|
|US6048352||May 16, 1997||Apr 11, 2000||Mercury Diagnostics, Inc.||Disposable element for use in a body fluid sampling device|
|US6056701||Dec 3, 1998||May 2, 2000||Amira Medical||Body fluid sampling device and methods of use|
|US6061128||Aug 24, 1998||May 9, 2000||Avocet Medical, Inc.||Verification device for optical clinical assay systems|
|US6066103||Apr 1, 1999||May 23, 2000||Amira Medical||Body fluid sampling device|
|US6068615||Nov 18, 1997||May 30, 2000||Health Hero Network, Inc.||Inductance-based dose measurement in syringes|
|US6071251||Dec 2, 1997||Jun 6, 2000||Abbott Laboratories||Method and apparatus for obtaining blood for diagnostic tests|
|US6071294 *||Dec 4, 1997||Jun 6, 2000||Agilent Technologies, Inc.||Lancet cartridge for sampling blood|
|US6086545||Apr 28, 1998||Jul 11, 2000||Amira Medical||Methods and apparatus for suctioning and pumping body fluid from an incision|
|US6093146||Jun 5, 1998||Jul 25, 2000||Matsushita Electric Works, Ltd.||Physiological monitoring|
|US6093156||Dec 2, 1997||Jul 25, 2000||Abbott Laboratories||Method and apparatus for obtaining blood for diagnostic tests|
|US6101478||Nov 21, 1997||Aug 8, 2000||Health Hero Network||Multi-user remote health monitoring system|
|US6113578||Jul 21, 1999||Sep 5, 2000||Health Hero Network, Inc.||Optical dose measurements in syringes|
|US6122536||Jul 8, 1996||Sep 19, 2000||Animas Corporation||Implantable sensor and system for measurement and control of blood constituent levels|
|US6144837||Dec 3, 1996||Nov 7, 2000||Health Hero Network, Inc.||Method and apparatus for interactively monitoring a physiological condition and for interactively providing health-related information|
|US6151586||Nov 21, 1997||Nov 21, 2000||Health Hero Network, Inc.||Computerized reward system for encouraging participation in a health management program|
|US6155267||Dec 31, 1998||Dec 5, 2000||Medtronic, Inc.||Implantable medical device monitoring method and system regarding same|
|US6161095||Dec 16, 1998||Dec 12, 2000||Health Hero Network, Inc.||Treatment regimen compliance and efficacy with feedback|
|US6167362||Mar 9, 1999||Dec 26, 2000||Health Hero Network, Inc.||Motivational tool for adherence to medical regimen|
|US6167386||May 3, 1999||Dec 26, 2000||Health Hero Network, Inc.||Method for conducting an on-line bidding session with bid pooling|
|US6168563||Mar 17, 1999||Jan 2, 2001||Health Hero Network, Inc.||Remote health monitoring and maintenance system|
|US6171325||Oct 20, 1999||Jan 9, 2001||Ganapati R. Mauze||Apparatus and method for incising|
|US6177931||Jul 21, 1998||Jan 23, 2001||Index Systems, Inc.||Systems and methods for displaying and recording control interface with television programs, video, advertising information and program scheduling information|
|US6228100 *||Oct 25, 1999||May 8, 2001||Steven Schraga||Multi-use lancet device|
|US6472220 *||Oct 13, 1999||Oct 29, 2002||Agilent Technologies, Inc.||Method of using cassette of lancet cartridges for sampling blood|
|US6530892 *||Mar 7, 2001||Mar 11, 2003||Helen V. Kelly||Automatic skin puncturing system|
|US6706159 *||Mar 2, 2000||Mar 16, 2004||Diabetes Diagnostics||Combined lancet and electrochemical analyte-testing apparatus|
|US6783537 *||Sep 3, 1999||Aug 31, 2004||Roche Diagnostics Gmbh||Lancet dispenser|
|USRE36191||Dec 19, 1996||Apr 20, 1999||Intel Corporation||Configuration data loopback in a bus bridge circuit|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7850910 *||Nov 10, 2006||Dec 14, 2010||Bayer Healthcare Llc||Compact foldable meter|
|US8105291 *||Jun 5, 2008||Jan 31, 2012||Ivonne Silvester||Device for storing and administering active substances|
|US8251920||Jan 13, 2010||Aug 28, 2012||Bayer Healthcare Llc||Swing lance with integrated sensor|
|US8292826||Nov 30, 2011||Oct 23, 2012||YofiMETER, Inc.||Cocking and advancing mechanism for analyte testing device|
|US8333716||Jul 20, 2011||Dec 18, 2012||Yofimeter, Llc||Methods for using an analyte testing device|
|US8333717||Nov 30, 2011||Dec 18, 2012||Yofimeter, Llc||Test unit cartridge for analyte testing device|
|US8556827 *||Feb 29, 2008||Oct 15, 2013||Abbott Laboratories||Lancing device|
|US8668656 *||Dec 31, 2004||Mar 11, 2014||Sanofi-Aventis Deutschland Gmbh||Method and apparatus for improving fluidic flow and sample capture|
|US8795200 *||Jul 31, 2008||Aug 5, 2014||Panasonic Healthcare Co., Ltd.||Piercing device and blood inspection device|
|US8852123||Dec 30, 2010||Oct 7, 2014||Roche Diagnostics Operations, Inc.||Handheld medical diagnostic devices housing with sample transfer|
|US8961432||Apr 23, 2013||Feb 24, 2015||Yofimeter, Llc||Analyte testing devices|
|US9072842||Jul 31, 2013||Jul 7, 2015||Sanofi-Aventis Deutschland Gmbh||Method and apparatus for penetrating tissue|
|US20090054812 *||Feb 29, 2008||Feb 26, 2009||Abbott Laboratories||Lancing device|
|US20100191147 *||Jul 31, 2008||Jul 29, 2010||Panasonic Corporation||Piercing device and blood inspection device|
|US20100292611 *||Dec 31, 2004||Nov 18, 2010||Paul Lum||Method and apparatus for improving fluidic flow and sample capture|
|WO2009132217A1||Apr 23, 2009||Oct 29, 2009||Pelikan Technologies, Inc.||Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means|
|WO2012177748A1||Jun 20, 2012||Dec 27, 2012||Yofimeter, Llc||Analyte testing device with lancet cartridge and test strip cartridge|
|WO2012177923A1||Jun 21, 2012||Dec 27, 2012||Yofimeter, Llc.||Cocking and advancing mechanism for analyte testing device|
| || |
|U.S. Classification||600/584, 600/583, 606/182|
|International Classification||A61B5/15, G01N37/00, A61B5/151, A61B5/157, A61B5/155, G01N33/96, A61B5/00, A61B5/1459, G01N33/487, B65D81/00|
|Cooperative Classification||A61B5/14532, A61B5/157, G01N33/96, A61B5/15146, A61B5/1455, A61B5/1411|
|European Classification||A61B5/145G, A61B5/157, A61B5/1455, G01N33/96, A61B5/14B2, A61B5/151M|
|May 19, 2003||AS||Assignment|
Owner name: PAUL-HARTMANN AG, GERMANY
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WURSTER, THOMAS;MALOWANIEC, KRZYSZTOF D.;DICKMANN, CHRISTOPH;REEL/FRAME:014411/0463;SIGNING DATES FROM 20030408 TO 20030411
|Dec 22, 2006||AS||Assignment|
Owner name: PELIKAN TECHNOLOGIES, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PAUL HARTMANN AG;REEL/FRAME:018671/0653
Effective date: 20060113
|May 23, 2012||AS||Assignment|
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PELIKAN TECHNOLOGIES, INC.;REEL/FRAME:028259/0051
Owner name: SANOFI-AVENTIS DEUTSCHLAND GMBH, GERMANY
Effective date: 20120131
|Jan 30, 2013||FPAY||Fee payment|
Year of fee payment: 4